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Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

NCT06516653 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-10-30

No results posted yet for this study

Summary

VasQ is an external support implant for arteriovenous fistulas created for dialysis access.

This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:

* Treatment arm: End to side fistula supported with VasQ
* Control: Standard of care end to side fistula

Conditions

Interventions

DEVICE

VasQ

External support implant for the arteriovenous fistula

PROCEDURE

Arteriovenous fistula creation for dialysis vascular access

End to side fistula creation in the arm for dialysis vascular access

Sponsors & Collaborators

  • Laminate Medical Technologies

    lead INDUSTRY

Principal Investigators

  • John F Lucas III, MD, FACS, FSVS · Greenwood Leflore Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2027-08-31
Completion
2028-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06516653 on ClinicalTrials.gov